ELREXFIO Patient Counseling Information
(elranatamab-bcmm)
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Cytokine Release Syndrome (CRS)
Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, tachycardia, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].
Neurologic Toxicity, Including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, encephalopathy, motor dysfunction, sensory neuropathy, and Guillain-Barré Syndrome. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurological toxicity symptoms until symptoms resolve [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].
ELREXFIO REMS
ELREXFIO is available only through a restricted program called ELREXFIO REMS. Inform patients that they will be given an ELREXFIO Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3)].
Infections
Discuss the signs and symptoms of infection [see Dosage and Administration (2.5), Warnings and Precautions (5.4)].
Neutropenia
Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5), Warnings and Precautions (5.5)].
Hepatotoxicity
Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with ELREXFIO and for 4 months after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:
Pfizer Inc.
NY, NY 10001
US License No. 2001
LAB-1518-1.0
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Health Professional Information
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Cytokine Release Syndrome (CRS)
Discuss the signs and symptoms associated with CRS, including fever, hypoxia, chills, hypotension, tachycardia, and elevated liver enzymes. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of CRS. Advise patients that they will be hospitalized for 48 hours after administration of the first step-up dose, and for 24 hours after administration of the second step-up dose [see Dosage and Administration (2.5), Warnings and Precautions (5.1)].
Neurologic Toxicity, Including Immune Effector Cell-associated Neurotoxicity Syndrome (ICANS)
Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including headache, encephalopathy, motor dysfunction, sensory neuropathy, and Guillain-Barré Syndrome. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving or operating heavy or potentially dangerous machinery for 48 hours after completing each of the 2 step-up doses and the first treatment dose within the ELREXFIO step-up dosing schedule and in the event of new onset of any neurological toxicity symptoms until symptoms resolve [see Dosage and Administration (2.5), Warnings and Precautions (5.2)].
ELREXFIO REMS
ELREXFIO is available only through a restricted program called ELREXFIO REMS. Inform patients that they will be given an ELREXFIO Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes signs and symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to immediately seek medical attention [see Warnings and Precautions (5.3)].
Infections
Discuss the signs and symptoms of infection [see Dosage and Administration (2.5), Warnings and Precautions (5.4)].
Neutropenia
Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Dosage and Administration (2.5), Warnings and Precautions (5.5)].
Hepatotoxicity
Advise patients that liver enzyme elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with ELREXFIO and for 4 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with ELREXFIO and for 4 months after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:
Pfizer Inc.
NY, NY 10001
US License No. 2001
LAB-1518-1.0
Health Professional Information
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